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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 878

Fuji Silysia Chemical Ltd.

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: Siloxanes and silicones, di-Me, hydroxyl-terminated, reaction products with silica (CAS Reg. No. 102782-80-9).
Notifier: Fuji Silysia Chemical Ltd.
Manufacturer: Fuji Silysia Chemical Ltd.
Intended Use: As an anti-blocking agent or slip agent in films and sheets manufactured from polypropylene (PP), and linear low density polyethylene (LLDPE) polymers, complying with applicable authorizations.
Limitations/Specifications*: For use at levels not exceeding 2 wt% of the finished films and sheets in contact with all types of food, except infant formula and food containing > 8% alcohol content, under Conditions of Use A through H (for PP) or B through H (for LLDPE), as described in Table 2.
Effective Date: May 12, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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